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FDA 510(k)

SINGLE USE LEE ELECTRODE

K-Number: K913213 · 1992-02-13

ApplicantAspen Laboratories, Inc.
Decision Date1992-02-13
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SINGLE USE LEE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1992-02-13 under 510(k) number K913213. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE LEE ELECTRODE?

SINGLE USE LEE ELECTRODE is a medical device that received FDA 510(k) clearance on 1992-02-13. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K913213.

When did SINGLE USE LEE ELECTRODE receive FDA 510(k) clearance?

SINGLE USE LEE ELECTRODE received FDA 510(k) clearance on 1992-02-13, under 510(k) number K913213.

Who is the listed applicant for SINGLE USE LEE ELECTRODE?

The FDA 510(k) record lists Aspen Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE USE LEE ELECTRODE?

The FDA product code for SINGLE USE LEE ELECTRODE is HGI.

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Related Devices (Code: HGI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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